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Single-use Sterile High-pressure Angiographic Syringes and Accessories
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref HT-SK501FSModel Type I : 25/60ml , 50/50ml, 50/100ml, 50/200ml, 60/60ml, 60/100ml, 60/200ml, 65/65ml, 65/115ml, 100/100ml, 100/200ml, 115/115ml, 125/125ml，130/200ml, 200/200ml, 65/200ml.
Identity
- Trade Name
- Single-use Sterile High-pressure Angiographic Syringes and Accessories EUDAMEDSinton Medical Products FDA UDI
- Generic Name
- Radiographic procedure tubing FDA UDI
- Device Name
- Single-use Sterile High-pressure Angiographic Syringes and Accessories EUDAMED1-21'' Transfer Set with Swabable Valve and Vented Spike FDA UDI
- Model / Reference
- Type I : 25/60ml , 50/50ml, 50/100ml, 50/200ml, 60/60ml, 60/100ml, 60/200ml, 65/65ml, 65/115ml, 100/100ml, 100/200ml, 115/115ml, 125/125ml，130/200ml, 200/200ml, 65/200ml. EUDAMEDHT-SK501FS EUDAMED700207-1C FDA UDI
- Description
- 1-21'' Transfer Set with Swabable Valve and Vented Spike FDA UDI
Identifiers
- Catalog Number
- HT-SK501FS FDA UDI
- Primary DI / UDI-DI
- 06938327909840 EUDAMEDFDA UDI
- Basic UDI-DI
- 69383279205XH EUDAMED
- FDA Product Code
- DXT FDA UDI
- EMDN Code
- A02010401 SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE EUDAMED
- GMDN Term
- Radiographic procedure tubing FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1650 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Angiography kit
Single-use Sterile High-pressure Angiographic Syringes and Accessories by Shenzhen Boon Medical Supply Co., Ltd. — Class IIa — MDR, FDA UDI — listed in…
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69383279205XH | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Boon Medical Supply Co., Ltd.
- EUDAMED SRN
- CN-MF-000018400
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED 49b1cb78-80ec-4fc6-8456-fadc8d666cc5 61 fields · synced Jun 19, 2026
- FDA UDI fb37ddd7-bbd8-4c0c-a51a-3cb65662596c 36 fields · synced May 27, 2026